Medline Industries, Inc.
Mundelein, IL, USA
Job Summary This role will be directly managing Medline’s Risk Management Team within the Regulatory Compliance department. Responsible for implementing and maintaining risk management processes throughout Medline’s Quality Management System. Job Description Responsibilities: Own and continually improve Medline’s risk management system (policy, SOPs, forms, templates) to ensure consistent, lifecycle‑wide application aligned to ISO 14971 and internal Design Control practices Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events. Represent Medline as risk management SME in BSI/MDSAP/FDA assessments; lead preparation, conduct real‑time issue resolution, and drive sustainable corrective actions. Act as a liaison with cross-functional teams such as Divisional risk management information is...